[18] (see also Agricultural vs. Healthcare Applications) That's what the Environmental Protection Agency said after downgrading ozone standards in the [6] (see also Regulatory Status) The FDA, however, continues to support the use of lindane prescription medications, noting that The risk of occupational/environmental exposure should be assessed separately and independent of the risk related to the therapeutic use of a medication to treat a medical condition where there is direct benefit to the patient. Cough. 89 0 obj <>stream WebThe table located at Appendix B to 172.101, List of Marine Pollutants, contains two columns. WebInternational initiatives on Lindane include the Protocol on Persistent Organic Pollutants of the Convention on Long Range Transboundary Air Pollution; the Rotterdam Convention; the OSPAR Commission for the Protection of the Marine Environment of the Northeast Atlantic, the Great ILO and WHO 2021. [6] Most exposure of the general population to lindane results from agricultural uses and the intake of contaminated foods, such as produce, meats and milk. [29] Modern manufacturing standards for lindane involve the treatment and conversion of waste isomers to less toxic industrial chemicals, a process known as cracking.[26][29] Today, only a few production plants remain active worldwide to accommodate public health uses of lindane and declining agricultural needs. The company seeks damages and injunctive relief against all of the defendants. At the same time, a boxed warning was added to the prescription label to highlight to healthcare providers appropriate use criteria and rare treatment risks. WebLindane is considered a marine pollutant, and special requirements have been set for marking, labeling, and transporting this material. [1][21] Similarly, no increased cancer risk was noted in a large epidemiologic study of lindane medications involving a 143,594-patient database with up to 21 years of follow up, which concluded that There is still no persuasive evidence from studies of humans that lindane, as ordinarily used clinically, is carcinogenic in humans. [22] Lindane in soil can leach to surface and even ground water and can bioaccumulate in the food chain. FDA-approved for the second-line treatment of scabies, pubic lice (crabs) and head lice. The width of the border forming the square-on-point marking must be at least 2 mm. 0000004014 00000 n 0000003168 00000 n 0000001466 00000 n UN Hazard Class: 6.1; UN Pack Group: III, Prepared by an international group of experts on behalf of ILO and WHO, (3) Except for transportation by vessel, on a bulk packaging, freight container or transport vehicle that bears a label or placard specified in subparts E or F of this part. (2) On a combination packaging containing a marine pollutant, other than a severe marine pollutant, in inner packagings each of which contains: (i) 5 L (1.3 gallons) or less net capacity for liquids; or. [4][6] It is banned in 52 countries and the state of California, and is under review for addition to the Stockholm Convention On Persistent Organic Pollutants. [7] Worldwide, effective treatment options for the control of scabies and lice are relatively limited. 0000003484 00000 n Animal tests show that this substance possibly causes toxicity to human reproduction or development. 2-ethyl-hexyl-4-trimethoxycinnamate (Octinoxate, Uvinul MC80) Glyceril octanoate dimethoxylcinnamate. 0 [4][25] The latter includes the U.S. and Canada, which support public health uses of pharmaceutical lindane but no longer allow agricultural applications. The EPA has approved the use of lindane stockpiles through 2009. [10] (see also Pharmaceutical Uses) Other countries, like Canada, similarly approve of pharmaceutical applications for lindane but no longer permit its broader use agriculturally. Your browser does not support JavaScript. This may result in convulsions. However, a significant amount of Lindane is also found in Marine pollutants or environmentally hazardous substances are materials that can pose a risk to aquatic ecosystems. Marine pollutant is a term mainly used by IMDG code while the term " environmentally hazardous substances " are used by other dangerous goods regulations such as ADR and IATA. Wear face shield or eye protection in combination with breathing protection. Personal protection: filter respirator for organic gases and particulates adapted to the airborne concentration of the substance, chemical protection suit including self-contained breathing apparatus and protective gloves. Boiling point: 323C Melting point: 113C Density: 1.9 g/cmSolubility in water, g/100ml at 20C: 0.0007 (very poor)Vapour pressure, Pa at 20C: 0.0012 Relative density of the vapour/air-mixture at 20C (air = 1): 1Octanol/water partition coefficient as log Pow: 3.61 - 3.72. Column 1 is labeled S.M.P. for Severe Marine Pollutants and Column 2 is DEA methoxycinnamate. Current as of October 03, 2022 | Updated by FindLaw Staff. "[14], The most common side effects associated with topical use of lindane medications are nonserious reactions of the skin, including burning, itching, dryness and rash. WebLindane is considered to be highly toxic to aquatic organisms, and moderately toxic to birds and mammals. WebSurface waters near industrialized and agricultural areas are contaminated with hundreds of different pollutants from a variety of sources. The companys promotion agreement with Alliant Pharmaceuticals, which commenced in 2005, was terminated May 2007. 0000001327 00000 n In the 1940s, lindane was registered with the U.S. Department of Agriculture (USDA), and in 1951 it was approved by the U.S. Food and Drug Administration (FDA) for medical use in the treatment of scabies, head lice and pubic lice (crabs). [1] Vomiting and nausea are usual symptoms associated with oral ingestions of lindane but serious neurologic effects can occur, albeit less frequently. The World Health Organization classifies lindane as "moderately hazardous", and its international trade is restricted and regulated under the Rotterdam Convention on Prior Informed Consent. In 2009, the production and agricultural use of lindane was banned under the Stockholm Convention on persistent organic pollutants. Do not eat, drink, or smoke during work. [25] In 2002, the EPA concluded that lindane agricultural products were eligible for re-registration given industry compliance with certain data and labeling requirements to mitigate occupational risks to workers. [15], The current FDA-approved product labeling emphasizes that lindane medications are contraindicated for use in premature infants and individuals with known uncontrolled seizure disorders and should be used with caution in infants, children, the elderly, and individuals with other skin conditions (e.g., atopic dermatitis, psoriasis) and in those who weigh less than 110 lbs (50 kg) as they may be at risk of serious neurotoxicity. In case of fire in the surroundings, use appropriate extinguishing media. 0000001244 00000 n (Note: These events represent the most common reported to the FDA and do not represent the most common events associated with the use of lindane lotion and lindane shampoo overall). It is also a recognised irritant. [7], In 1995, lindane medications were designated second-line and are now reserved for patients who are unable to tolerate or have failed first-line treatmentsa growing problem in the U.S. and elsewhere due to increased rates of resistance. 0000050404 00000 n WebThe MARINE POLLUTANT mark must conform to the following: (1) Except for size, the MARINE POLLUTANT mark must appear as follows: Symbol (fish and tree): Black on 0000006190 00000 n The symbol and border must be black on a white or suitable contrasting background. Ethyl-4-aminobenzoate. To use all functions of this page, please activate cookies in your browser. It has an oral LD50 of 88 mg/kg in rats and a dermal LD50 of 1000 mg/kg. Web( d) The MARINE POLLUTANT mark is not required ( 1) On single packagings or combination packagings where each single package or each inner packaging of combination packagings has: ( i) A net quantity of 5 L (1.3 gallons) or less for liquids; or ( ii) A net [28] More specifically, the EPA conducted down-the-drain estimates of the amount of lindane reaching public water supplies from the use of lindane medications using data from California water treatment facilities, concluding that lindane levels from pharmaceutical sources were extremely low and not of concern.[5]. The mark may be displayed in black lettering on a square-on-point configuration having the same outside dimensions as a placard; or. 0000057176 00000 n Access to page content (press "Enter") Lindane and Environmental Protection Agency (EPA) Bioaccumulation of this chemical may occur along the food chain, for example in fish and seafood. The most common side effects are nonserious reactions of the skin (e.g., burning, itching, dryness and rash). Physical State; Appearance Each side of the mark must be -. 0000005726 00000 n Dizziness. (2) Except as otherwise provided in this subchapter, the MARINE POLLUTANT mark shall be placed in association with the hazard warning labels required by subpart E of this part or, in the absence of any labels, in association with the marked proper shipping name. [7] [17] When used properly, lindane medications are safe and effective for the diseases they are approved. xb```"cV @16$!Lvr p'wO'w6%nY38rg?&')(Iq^ YNH(Hinthr;.5. Transportation Lindane is moderately toxic to mammals and may be a neurotoxin. The substance may cause effects on the central nervous system. (ii) 5 kg (11 pounds) or less net capacity for solids. [1] The ecological impact of lindanes environmental persistence continues to be debated. This substance does enter the environment under normal use. That's what the Environmental Protection Agency said after downgrading ozone standards in the northern front range from "serious" to "severe." Larger than the issue of lindane toxicity are concerns related to the non-gamma isomers of HCH, namely alpha-HCH and beta-HCH, which are notably more toxic than lindane. hYio+QB L` EDl+b?5 %U`{W5=;" C*LOu3],5K1v)v..%S]*&dc?>|]^+}.{|xu}>_]_og|Sn6?8WagnsyY~9,6lY|y /7buvx|~\^sgd_ yr|t1g/7o_7:E}stm"(:KjuygEwq^|_]. In 2003, the FDA published a safety analysis of adverse events reported in association with the use of lindane medications received through its adverse event monitoring system (AERS database) between from 1974 through 2002. Carefully collect remainder. Routes of exposure The authors concluded that "The California experience suggests elimination of pharmaceutical lindane produced environmental benefits, was associated with a reduction in reported unintentional exposures and did not adversely affect head lice and scabies treatment. Vlkov and Hofman demonstrated that soil properties affect the bioavailability of persistent organic pollutants such as lindane, DDT, phenanthrene and %PDF-1.6 % [23] However, more recent evaluations by subject matter experts do not support this rating. (ii) At least 250 mm (9.8 inches) for marks applied to all other bulk packages. The mark must be visible from the direction it faces. Web4-methylbenzylidene camphor. Headache. Symbol (fish and tree): Black on white or suitable contrasting background. [15] (see also Pharmaceutical Uses) Lindane has not been shown to alter immunocompetence in humans and is not considered to be genotoxic.

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